[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)]
[Notices]
[Pages 50638-50639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20557]
[[Page 50638]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-2768]
Collecting On-Farm Antimicrobial Use and Resistance Data; Public
Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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The Food and Drug Administration (FDA), in collaboration with the
U.S. Department of Agriculture (USDA) and the Centers for Disease
Control and Prevention (CDC), is announcing plans for a jointly
sponsored public meeting to obtain public input on possible approaches
for collecting additional on-farm antimicrobial drug use and resistance
data. Such data are important for assessing the impact of measures
being implemented to foster the judicious use of medically important
antimicrobial drugs in food-producing animals.
Date and Time: The public meeting will be held September 30, 2015,
from 8 a.m. to 4:30 p.m. Although you can comment on the interagency
plan for collecting on-farm antimicrobial drug use and resistance data
at any time, to ensure that the Agencies consider your comment before
updating this plan, submit either electronic or written comments by
November 30, 2015.
Location: The public meeting will be held in the USDA Jefferson
Auditorium (South Building), 1400 Independence Avenue SW., Washington,
DC 20250. Please arrive between 7 a.m. and 7:30 a.m. to provide time to
get through security. Attendees must provide a valid government issued
photo ID (Driver's License, Identification Card, or Passport) to enter
the facility. Attendees should enter the building via Wing 5 on the
Independence Avenue side of the building. The South Building is
accessible by the Smithsonian Metro station (exit Metro station through
the ``Independence Avenue Exit'' and walk toward 15th Street on
Independence Avenue to reach Wing 5). For more information on
directions and parking, visit http://smithsonianassociates.org/ticketing/help/locations/jefferson.htm.
Contact Person: Kelly Covington, Center for Veterinary Medicine
(HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD
20855, 240-402-5661, FAX: 240-276-9020, email:
[email protected].
Registration and Requests for Oral Presentations: Registration is
required for this public meeting. Please send registration information
(including name, title, organization, address, telephone and fax
numbers) by email to [email protected] by September 18, 2015.
There is no fee to register for the public meeting, and registration
will be on a first-come, first-served basis. If you need special
accommodations due to a disability, please contact Kelly Covington (see
Contact Person) at least 7 days in advance.
Oral presentations can be made by members of the public during the
open public comment period of the public meeting. These presentations
will be scheduled between approximately 3 p.m. and 4 p.m. on September
30, 2015. Those persons desiring to make an oral presentation should
notify the contact person listed in this notice by September 16, 2015,
and submit a brief statement of the general nature of information they
wish to present. In an effort to accommodate all who desire to speak,
time allotted for each presentation may be limited. The contact person
will inform each speaker prior to the meeting of the time they are
scheduled to speak.
Comments: Regardless of attendance at the public meeting,
interested persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, by (see Date and Time). It is only
necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Antimicrobial drugs have been widely used in human and veterinary
medicine for more than 50 years, with tremendous benefits to both human
and animal health. The development of resistance to this important
class of drugs, and the resulting loss of their effectiveness as
antimicrobial therapies, poses a serious threat to public and animal
health. Because antimicrobial drug use can contribute to the emergence
of drug-resistant organisms, these important drugs must be used
judiciously in both animal and human medicine to slow the development
of resistance.
In December 2013, FDA published Guidance for Industry (GFI) #213
(http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf), which
calls on animal drug sponsors of approved medically important
antimicrobials administered through medicated feed or water to
voluntarily remove production (growth promotion and feed efficiency)
uses from their product labels, and bring the remaining therapeutic
uses of these products (to treat, control, or prevent disease) under
the oversight of a veterinarian by the end of December 2016. All 25
affected drug sponsors have committed to implementing the changes
described in GFI #213 by the December 2016 target date. Once the
changes are fully implemented, it will be illegal to use these
medically important antibiotics for production purposes, and animal
producers will need to obtain authorization from a licensed
veterinarian to use them for prevention, control, or treatment of a
specifically identified disease.
On March 27, 2015, the White House released the National Action
Plan for Combating Antibiotic-resistant Bacteria (``National Action
Plan'') (https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf).
Developed in response to Executive Order 13676, which was issued by
President Barack Obama on September 18, 2014, the National Action Plan
is intended to guide the activities of the U.S. Government as well as
the actions of public health, health care, and veterinary partners in a
common effort to address the urgent and serious public health threat of
drug-resistant bacterial infections. Objective 2.4 of the National
Action Plan is to enhance monitoring of antibiotic resistance patterns,
as well as antibiotic sales, usage, and management practices, at
multiple points in the production chain for food animals and retail
meat. The public meeting being announced in this Federal Register
notice is consistent with Sub-Objective 2.4.3 of the National Action
Plan, which calls for the USDA and FDA to seek public input on a plan
for collecting drug use and resistance data on farms.
In April 2015, USDA's Animal and Plant Health Inspection Service
published an Info Sheet entitled ``Proposed Initiatives From the USDA
Antimicrobial Resistance Action Plan'' (http://www.aphis.usda.gov/animal_health/nahms/amr/downloads/ProposedInitiatives.pdf). The Info
Sheet provides a brief synopsis of initiatives
[[Page 50639]]
proposed in the USDA Action plan, including a number of initiatives
related to collecting on-farm antibiotic use and resistance data.
Gathering information on the way medically important antimicrobials
are used in food-producing animals is essential to measuring the impact
of the FDA's GFI #213. FDA is collaborating with USDA and CDC to
develop a plan for collecting additional on-farm data on antimicrobial
use and resistance. Such data are intended to supplement existing
information, including data on the quantity of antimicrobials sold or
distributed for use in food-producing animals (reported under section
105 of the Animal Drug User Fee Amendments of 2008) and data on
antimicrobial resistance (e.g., collected under the National
Antimicrobial Resistance Monitoring System and the National Animal
Health Monitoring System). Data from multiple sources are needed to
provide a comprehensive and science-based picture of antimicrobial drug
use and resistance in animal agriculture.
A data collection plan is needed to obtain additional information
necessary to: (1) Assess the rate of adoption of changes outlined in
the FDA's GFI #213; (2) help gauge the success of antibiotic
stewardship efforts and guide their continued evolution and
optimization; and (3) assess associations between antibiotic use
practices and resistance. FDA is continuing to work with the USDA and
CDC in developing this plan, and is holding this public meeting in
order to obtain input from the public. This meeting is the first
opportunity for public input as part of our ongoing effort to develop
and implement plans for collecting additional on-farm antimicrobial
drug use and resistance data.
II. Agenda
The public meeting will provide an opportunity for public comment
on possible approaches for collecting additional antimicrobial drug use
data. The final agenda for the public meeting will be made available on
the Agency's Web site at
http://www.fda.gov/AnimalVeterinary/NewsEvents/WorkshopsConferencesMeetings/ucm456380.htm no later than 2 weeks prior
to the meeting.
III. Transcript
FDA will prepare a meeting transcript and make it available on the
Agency's Web site (see section II) after the meeting. FDA anticipates
that the transcript will be available approximately 60 business days
after the meeting. A copy of the transcript will be available for
public examination at the Division of Dockets Management (see Comments)
between 9 a.m. and 4 p.m., Monday through Friday. In addition, copies
of the transcript will be available in either hardcopy or on CD-ROM
after submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's Web site at
http://www.fda.gov.
Dated: August 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20557 Filed 8-19-15; 8:45 am]
BILLING CODE 4164-01-P